Shuttle Pharma Provides Fourth Quarter 2023 Corporate Update

Rhea-AI Summary

Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) provided a corporate update, highlighting FDA approval for Phase 2 Clinical Trial of Ropidoxuridine for glioblastoma, creation of Shuttle Diagnostics, licensing agreements, exclusive intellectual property acquisitions, and a planned Rights Offering to raise $4.5 million. The company's cash balance was $5.5 million as of December 31, 2023. Recent presentations included participation in investor conferences and updates on radiation sensitizer portfolio and diagnostic subsidiary.

Insights

Oncology Medical Research Analyst

The FDA's approval for Shuttle Pharma to proceed with a Phase 2 Clinical Trial for Ropidoxuridine is a pivotal step for the company. This drug, aimed at treating glioblastoma, addresses a significant unmet medical need due to the aggressive nature of this brain cancer and the limited efficacy of current treatments. The trial's outcome could have profound implications for patient survival rates and quality of life, potentially leading to increased investment in the company if the results are positive.

Furthermore, the creation of Shuttle Diagnostics, Inc. signifies a strategic move into the companion diagnostics market, which is becoming increasingly important in personalized medicine. By developing a predictive diagnostic test for prostate cancer patients considering radiation therapy, Shuttle Pharma is not only broadening its portfolio but also tapping into a growing market segment that values precision in cancer treatment.

Financial Analyst

The announcement of Shuttle Pharma's Rights Offering to raise up to $4.5 million is a critical financial maneuver that reflects the company's proactive approach to funding its ambitious projects. With a cash balance of $5.5 million at the end of 2023, the additional funds could significantly bolster the company's ability to advance its diagnostic subsidiary and fund ongoing clinical trials.

Investors should note, however, that such offerings can dilute existing shares, potentially impacting share value. The success of the Rights Offering and subsequent deployment of capital will be key factors in assessing the company's financial health and growth prospects.

Market Research Analyst

The estimated global prostate cancer diagnostic market was valued at $2.83 billion in 2019 and Shuttle Pharma's entry into this space with a predictive diagnostic test could capture a notable market share, especially considering the current gap in predictive tests for radiation therapy success. The licensing of intellectual property from Georgetown University and the exclusive license for PSMA-B intellectual property suggest strategic moves to secure a competitive edge in the market.

Investors should monitor the adoption rate of Shuttle Pharma's diagnostic tests upon commercialization, as this will be a critical indicator of the company's potential to secure a foothold in the diagnostics market. Additionally, the company's focus on leveraging radiation sensitizers to improve cancer treatment outcomes could position it favorably in the oncology market, pending the results of the clinical trials.

GAITHERSBURG, Md., March 21, 2024 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma"), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), today provided a corporate update in connection with the filing of its Annual Report on Form 10-K for the year ended December 31, 2023.

Recent Highlights

• Received FDA approval to proceed with the Phase 2 Clinical Trial of Ropidoxuridine for treatment of patients with glioblastoma, a deadly malignancy of the brain with no known cure.
• Finalizing site enrollment with 'first patient, first dose' expected in the second quarter of 2024.
• Created Shuttle Diagnostics, Inc., a wholly owned subsidiary of Shuttle Pharma, focused on developing a diagnostics laboratory to develop its metabolite discovery platform technology and to perform multi-institutional clinical trials.
  • Entered into an exclusive agreement to license certain intellectual property from Georgetown University to advance the Company's predictive biomarker program focused on developing a predictive diagnostic test for prostate cancer patients who are considering elective radiation therapy.
• Obtained an exclusive license for PSMA-B intellectual property for advancing research into diagnostic and therapeutic applications of metastatic prostate cancer. Announced intent to commence a Rights Offering where it plans to raise up to $4.5 million through the distribution of subscription rights and the exercise thereof to advance Shuttle Diagnostics, Inc. Details of the Rights Offering can be found here.
• At December 31, 2023, Shuttle Pharma's cash balance was $5.5 million (including cash, cash equivalents and marketable securities).

Recent Presentations

• Anatoly Dritschilo, M.D., Chief Executive Officer of Shuttle Pharma, participated in a fireside chat at the Lytham Partners 2024 Investor Select Conference. The webcast can be accessed HERE.
• Shuttle Pharma presented at the Emerging Growth Conference on March 6, 2024. A webcast link of the presentation can be found on the investor relations page of Shuttle Pharma's website or accessed HERE.
• Updated corporate slide presentation to highlight the opportunity for both Shuttle Pharma's radiation sensitizer portfolio as well as the diagnostic subsidiary.

"We achieved a significant milestone in January 2024 with the receipt of the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) to commence Ropidoxuridine's Phase 2 clinical trial," stated Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "We are currently finalizing site enrollment with 'first patient, first dose' expected in the second quarter of 2024. The results of this Phase 2 clinical trial will be important as we look to leverage radiation sensitizers to increase cancer cure rates, prolong patient survival, and improve the quality of life for patients suffering from glioblastoma.

"Beyond our focus on radiation sensitizers through both our Ropidoxuridine and HDAC6 development, we also announced the formation of Shuttle Diagnostics, which is focused on developing pretreatment predictive blood tests for prostate cancer patients. These tests will allow for the assessment of risk for cancer treatment success or failure, while informing therapeutic decision making and follow-up management. In 2019, the estimated global prostate cancer diagnostic market was $2.83 billion, however, none of the currently available tests are predictive of success of a specific treatment. We aim to meet this key unmet need for a minimally invasive diagnostic test that provides the clinician and patient with a measurement of the potential success of RT for their cancer treatment.

"We expect the coming few months will be filled with key developments and milestones, including the commencement of our Phase 2 clinical trial for Ropidoxuridine for treatment of patients with glioblastoma and the advancement of our opportunity within diagnostics. Our team is laser-focused on execution of the key deliverables that we believe will drive value for both patients and shareholders," Dr. Dritschilo concluded.

About Shuttle Pharmaceuticals

Founded in 2012 by faculty members of the Georgetown University Medical Center, Shuttle Pharma is a discovery and development stage specialty pharmaceutical company focused on improving the outcomes for cancer patients treated with radiation therapy (RT). Our mission is to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment. Although RT is a proven modality for treating cancers, by developing radiation sensitizers, we aim to increase cancer cure rates, prolong patient survival and improve quality of life when used as a primary treatment or in combination with surgery, chemotherapy and immunotherapy. For more information, please visit our website at www.shuttlepharma.com.

Safe Harbor Statement

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." These statements include, but are not limited to, statements concerning the development of our company. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including factors discussed in the "Risk Factors" section of Shuttle Pharma's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 21, 2024, as well other SEC filings. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, Shuttle Pharmaceuticals specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Shuttle Pharmaceuticals
Anatoly Dritschilo, M.D., CEO
240-403-4212
info@shuttlepharma.com

Investor Contacts
Lytham Partners, LLC
Robert Blum
602-889-9700
shph@lythampartners.com 

 

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SOURCE Shuttle Pharmaceuticals Holdings, Inc.

FAQ

What is the ticker symbol for Shuttle Pharmaceuticals Holdings, Inc.?

The ticker symbol for Shuttle Pharmaceuticals Holdings, Inc. is SHPH.

What recent FDA approval did Shuttle Pharma receive?

Shuttle Pharma received FDA approval to proceed with the Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma.

What is the focus of Shuttle Diagnostics, Inc.?

Shuttle Diagnostics, Inc. is focused on developing a diagnostics laboratory to advance metabolite discovery platform technology and perform multi-institutional clinical trials.

What agreement did Shuttle Pharma enter into with Georgetown University?

Shuttle Pharma entered into an exclusive agreement to license certain intellectual property from Georgetown University to advance the Company's predictive biomarker program for prostate cancer patients.

How much does Shuttle Pharma plan to raise through the Rights Offering?

Shuttle Pharma plans to raise up to $4.5 million through the Rights Offering.

What was Shuttle Pharma's cash balance as of December 31, 2023?

Shuttle Pharma's cash balance was $5.5 million as of December 31, 2023.

Who is the Chief Executive Officer of Shuttle Pharma?

The Chief Executive Officer of Shuttle Pharma is Anatoly Dritschilo, M.D.